Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT01533116
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01533116
Study Brief:
Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28. Placebo levodopa/carbidopa levodopa/benserazide | None | None | 0 | 14 | 11 | 14 | View |
| 5 mg BIA 9-1067 | 5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 BIA 9-1067 levodopa/carbidopa levodopa/benserazide | None | None | 0 | 13 | 9 | 13 | View |
| 15 mg BIA 9-1067 | 15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 BIA 9-1067 levodopa/carbidopa levodopa/benserazide | None | None | 0 | 13 | 11 | 13 | View |
| 30 mg BIA 9-1067 | 30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 BIA 9-1067 levodopa/carbidopa levodopa/benserazide | None | None | 0 | 12 | 9 | 12 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ear discomfort | None | Ear and labyrinth disorders | None | View |
| Ear pain | None | Ear and labyrinth disorders | None | View |
| Dark circles under eyes | None | Eye disorders | None | View |
| Eye pain | None | Eye disorders | None | View |
| Eye pruritus | None | Eye disorders | None | View |
| Ocular hyperaemia | None | Eye disorders | None | View |
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Abdominal pain upper | None | Gastrointestinal disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Diarrhoea | None | Gastrointestinal disorders | None | View |
| Eructation | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Chest discomfort | None | General disorders | None | View |
| Chills | None | General disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Feeling hot | None | General disorders | None | View |
| Vessel puncture site reaction | None | General disorders | None | View |
| Upper respiratory tract infection | None | Infections and infestations | None | View |
| Excoriation | None | Injury, poisoning and procedural complications | None | View |
| Sunburn | None | Injury, poisoning and procedural complications | None | View |
| Blood potassium increased | None | Investigations | None | View |
| Hepatic enzyme increased | None | Investigations | None | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Muscle spasms | None | Musculoskeletal and connective tissue disorders | None | View |
| Disturbance in attention | None | Nervous system disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Dysgeusia | None | Nervous system disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Hypoaesthesia | None | Nervous system disorders | None | View |
| Sensory disturbance | None | Nervous system disorders | None | View |
| Somnolence | None | Nervous system disorders | None | View |
| Euphoric mood | None | Psychiatric disorders | None | View |
| Polyuria | None | Renal and urinary disorders | None | View |
| Urine odour abnormal | None | Renal and urinary disorders | None | View |
| Dysmenorrhoea | None | Reproductive system and breast disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Nasal congestion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Acne | None | Skin and subcutaneous tissue disorders | None | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | None | View |
| Eczema | None | Skin and subcutaneous tissue disorders | None | View |
| Erythema | None | Skin and subcutaneous tissue disorders | None | View |
| Photosensitivity reaction | None | Skin and subcutaneous tissue disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Rash maculo-papular | None | Skin and subcutaneous tissue disorders | None | View |
| Skin hyperpigmentation | None | Skin and subcutaneous tissue disorders | None | View |
| Hot flush | None | Vascular disorders | None | View |